Clinical Trials
eQcell conducts clinical trials for the initial purpose of animal drug approvals. In many instances these animal data will be of pre-clinical value for similar drug development strategies for the development of human drugs.
eQcell’s dual-purpose use of animal data is a uniquely responsible product development strategy for human stem cell therapeutics in regenerative therapies for non-life-threatening disorders since it includes the evaluation of safety and efficacy using genetically-diverse, relevant large animal models of spontaneous disease.
eQcell currently have two clinical trials open for enrolment. These trials are designed to produce data to inform pivotal trials anticipated for initiation in 2022 for the purpose of initial marketing application in horses in Europe in 2023, followed by submissions to North American and international regulatory bodies. Additionally, positive data from the equine trials will be utilized to support similar studies in humans and canines, consistent with One Health principles and eQcell’s paradigm of dual-purpose clinical trials.
Proof-of-Concept, Randomized, Blinded, Clinical Trials in Equine Osteoarthritis
using allogeneic stem cell preparations.
Partners:
UC Davis Institute for Regenerative Cures
University of Guelph's Ontario Veterinary College Equine Sports Medicine Centre
Lead Investigators:
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Dr. Frank Barry (Regenerative Medicine Institute, National University of Ireland Galway)
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Dr. Larry Galuppo (Veterinary Institute for Regenerative Cures, UC Davis School of Veterinary Medicine)
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Dr. Laurie Goodrich (Orthopaedic Research Center, Colorado State University's C. Wayne McIlwraith Translational Medicine Institute)
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Dr. Judith Koenig (Equine Sports Medicine & Reproduction Centre, Ontario Veterinary College)
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Dr. Scott Hopper (Rood & Riddle Equine Hospital, Kentucky)
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Dr. Thomas Koch (Department of Biomedical Sciences, Ontario Veterinary College)
Study Type: Interventional
Estimated Enrollment: Up to 45 horses at each location
Allocation: Randomized
Masking: Single (investigator)
Primary Purpose: Treatment
Start date: August 1, 2021
Estimated Primary Completion Date: June 1, 2022
Clinical trial information may be addressed to:
Dr. Larry Galuppo – Veterinary Institute for Regenerative Cures, UC Davis – ldgaluppo@ucdavis.edu
Dr. Judith Koenig – Equine Sports Medicine & Reproduction Centre, Ontario Veterinary College – jkoenig@uoguelph.ca